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Job Details

Lead Clinical Data Manager - EMEA

Company: Quintiles
Location: Dublin
Reference: 1604120
Closing Date: 20 Dec 16
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

PURPOSE  Manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. ...

Requirements:

PURPOSE
 
Manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, and/or a leadership role in a specific CDM task (e.g. Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.
 
RESPONSIBILITIES
 
Client Management:

  • Serve as primary point of contact for customer on data management deliverables
  • Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
  • Provide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resources
  • Maintain strong customer relationships
  • Ensure open communications with customer and Quintiles management to manage and meet contractual obligations
     
    Service Management:
     
  • Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables
  • Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
  • Support DM service delivery with comprehensive DM process and technical expertise in executing projects
  • Serve as the escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution
  • Work with functional manager(s) to ensure appropriate resources are assigned to meet project deliverables
  • Create and/or review and sign-off on all data management plan (DMP) documents
  • Ensure service and quality meet agreed upon specifications per the DMP and contract/SOW
  • Implement proactive quality management plans across multiple projects/programme. Track service performance and provide leadership to identify root causes of issues and implement remedial actions
  • Continuously look for opportunities to improve service; work with team to develop and implement plan to re-organise and drive change across multiple projects/programme (with minimal support)
  • Ensure timely follow-up and resolution of compliance issues
  • Serve as Subject Matter Expert (SME)
  • Provide leadership and expertise in a specific CDM task or technology
  • Train and mentor junior DTL staff in DM expertise. May coordinate the work of more junior DTL staff
  • Maintain internal tracking databases and systems
     
    Financial Management/Business Development Support:
  • Ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW)
  • Manage SOW/budget
  • Review financial reports on a monthly basis and participate in project reviews as requested
  • Identify out of scope tasks and track change orders to completion
  • Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing
  •  Participate in and support RFP process (review RFP documents, pricing, attend bid defense)
              Other:
  • Independently bring solutions to the CDM team/CDM department
  • Lead and/or participate in a focus team or global or local best practice team
  • Communicate lessons learned and/or present in CDM workshop(s)
  • Participate in the development and implementation of new technology or tool
  • Present at professional conferences and/or publish articles in professional journals
  • Provide review and input on developing, revising, and maintaining core operating procedures and work instructions
  • Perform other duties as directed by the functional manager

 

 

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
  • Previous experience and proven competence in managing delivery of multiple projects through full DM life-cycle (several studies/programmes)
  • Demonstrated expert data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)
  • Previous experience of handling customer negotiations
  • Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
  • Knowledge of operating procedures and work instructions and the ability to apply them in practice
  • Knowledge of Good Clinical Practices and relevant regulatory guidelines
  • Excellent communication, interpersonal, customer service, and teamwork skills
  • Excellent project management skills
  • Excellent organizational and problem-solving skills
  • Ability to work independently with available resources, e.g., functional managers, senior DTLs
  • Comprehensive understanding of clinical drug development process
  • Ability to establish and maintain effective working relationships with coworkers, managers and customers
     
    MINIMUM REQUIRED EDUCATION AND EXPERIENCE
  • Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field, and a minimum of 5 years direct Data Management experience, including 3 or more years as a CDM project lead; or equivalent combination of education, training and experience
     
    PHYSICAL REQUIREMENTS
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Regular sitting for extended periods of time
  • Occasional travel is required

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